Job Summary
The ideal candidate will have a strong manufacturing and quality background, is self-motivated, strategic
and team focused. This is an exciting and unique role, where the candidate will take ownership of
quality systems, compliance, and data analysis for revolutionary technologies. Proven communication
and team building skills are essential to success. We are looking for a candidate who can be a key
contributor and leader on a talented and diverse team to meet both quality and customer expectations.Key Characteristics Proficient with data analysis, data analysis tools (e.g. JMP), and other software tools (e.g. Salesforce and SAP)Ability to prioritize assignments, handle multiple tasks, and innovate continuous improvement in a fast-paced life science industryManufacturing and testing of analytical instrumentsLeadership skills with the ability to lead indirect teams and provide guidance to othersAbility to drive continuous improvement with minimal direct oversightUnderstanding of manufacturing and new product introduction processesProblem solving, attention to detail and emotional intelligenceCollaboration, team building, and ability to lead changeKnowledge of compliance and regulatory requirements for ISO 9001 and Life Science industryDuties & Responsibilities Lead cross-functional quality improvement teams ensuring quality activities and plans are formulated and followed and key quality metrics are metIdentify and lead application of quality tools (e.g. RCA, FMEA, CAPA) on internal manufacturing processes, customer support processes, supplier processes, and continuous improvement.Drive process validation, monitoring and control at critical suppliers and internally using data analysis software tools (e.g. JMP) and conduct Design of Experiments for critical product parameters.Present supplier and customer data to various internal and external audiences.Facilitate and review quality activities for parts approval, supplier manufacturing processes (control plans, assembly instructions) and confirm process capability.Investigate internal or customer product quality problems, determine root cause, gather and analyze data and implement corrective/preventive actions for non-conformance. Author Failure Analysis Reports with Product Management.Create critical manufacturing and QC laboratory operating procedures and approve all changesParticipate as a core team member on new product development and introduction teams.